Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07685249
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sex Therapy — BEHAVIORAL
    Telehealth sex therapy integrating psychoeducation, acceptance and commitment therapy strategies, and sensate focus skills; 10 sessions (\~45 minutes) over 6 months delivered by a psychologist.
  • Pelvic Floor Physical Therapy — BEHAVIORAL
    Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
  • Vacuum Erection Device (VED) — DEVICE
    FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.

Study Details

This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment. All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone. Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: PFPT + Sex Therapy
    Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).
  • Active Comparator: PFPT Alone (Standard Care)
    Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy.

Primary Outcome Measure

Recruitment feasibility as measured by number of participants recruited [ Time Frame: From initiation of recruitment to completion of accrual, up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Michael W Willis, BA
[email protected]
919-681-8437
Smrithi Divakaran, MPH
[email protected]
919-681-7695
Rebecca A Shelby, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Duke University Medical Center· Durham, NC

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